FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MINICAP TM 100 CAPNOMETER
K Number: K883090
·
Decision Jan 30, 1989
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
304
Applicant Total
5
Review Days
192
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Basic Information
- Device Name
- MINICAP TM 100 CAPNOMETER
- K Number
- K883090
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1400
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Minesafety Appliances Co.
- Date Received
- July 22, 1988
- Decision Date
- January 30, 1989
- Product Code
- CCK
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | FDA class 2 | Anesthesiology |
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Other Clearances by Minesafety Appliances Co.
| K Number | Device Name | ||
|---|---|---|---|
| K961644 | MINIOX 3000 OXYGEN MONITOR | Jul 25, 1996 | Substantially Equivalent |
| K935370 | MINIOX IA OXYGEN ANALYZER | Aug 2, 1994 | Substantially Equivalent |
| K935364 | MINIOX 1000 OXYGEN CONCENTRATION INDICATOR | Jun 14, 1994 | Substantially Equivalent |
| K903200 | MINICAP III CO2 DETECTOR | Sep 21, 1990 | Substantially Equivalent |